NIMOTOP INFUSION SOLUTION 0.02% 50ML

Țară: Malaezia

Limbă: engleză

Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredient activ:

NIMODIPINE

Disponibil de la:

BAYER CO. (MALAYSIA) SDN. BHD.

INN (nume internaţional):

NIMODIPINE

Unități în pachet:

50ml mL

Produs de:

BAYER AG

Caracteristicilor produsului

Reference: Nimotop / solution for infusion / CCDS / Version 05 / Rebranding and Rena ming
Nimotop® (aSAH)
1. NAME OF THE MEDICINAL PRODUCT
Nimotop solution for infusion 10 mg (50 mL)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 bottle of Nimotop solution for infusion 10 mg (50 mL) contains 10 mg nimodipine in
50 mL alcoholic solvent.
3. PHARMACEUTICAL FORM
Clear slightly yellowish solution
4. CLINICAL PARTICULARS
4.1 Indication(s)
Prophylaxis and treatment of ischemic neurological deficits caused by cerebral
vasospasms following subarachnoid hemorrhage of aneurysmal origin.
4.2 Dosa ge and m ethod of administration
4.2.1 Method of administration
Nimotop solution for infusion is administered as a continuous i.v. infusion via a central
catheter using an infusion pump. It should be given via a three -way stopcock together
with either gluco se 5%, sodium chloride 0.9%, lactated Ringer's solution, lactated
Ringer's solution with magnesium, dextran 40 solution or HAES® (poly(O -2-
hydroxyethyl) starch 6% in a ratio of about 1:4 (nimodipine: co -infusion). Also ma nnitol,
human albumin or blood are suitable for co -infusion.
The three -way stopcock should be used to connect the nimodipine polyethylene tube with
the co infusion line and the central catheter.
Nimotop solution for infusion must not be added to an infusion bag or bottle and must not
be m ixed with other drugs.
Administration of Nimotop solution for infusion should be continued during anesthesia,
surgery and angiography.
4.2.2 Dosage regimen
Intravenous infusion:
At the beginning of treatment 1 mg/h nimodipine (= 5 mL Nimotop solution for infusion
/h) for 2 h (about 15 µg/kg body weight/h).
If this is well tolerated, and particularly if there is no marked reduction in blood pressure,
the dose is increased after 2 h to 2 mg/h nimodipine (= 10 mL Nimotop solution for
infusion /h) (about 30 µg/kg body weight/h).